Trial Outcomes & Findings for Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients (NCT NCT00675103)

NCT ID: NCT00675103

Last Updated: 2011-06-28

Results Overview

Number of participants reporting events

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2011-06-28

Participant Flow

Participant milestones

Measure	Pegloticase 8 mg Every 2 Wks
Overall Study STARTED	7
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Pegloticase 8 mg Every 2 Wks
Overall Study Lack of Efficacy	2
Overall Study Adverse Event	1

Baseline Characteristics

Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

Baseline characteristics by cohort

Measure	Pegloticase 8 mg Every 2 Wks n=7 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	66.4 years STANDARD_DEVIATION 8.77 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants reporting events

Outcome measures

Measure	Pegloticase 8 mg Every 2 Wks n=7 Participants
Adverse Event Profile Adverse Events	7 Number of participants
Adverse Event Profile Serious Adverse Events	2 Number of participants

SECONDARY outcome

Timeframe: Baseline, Week 3 and Week 7

Population: ITT population

This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.

Outcome measures

Measure	Pegloticase 8 mg Every 2 Wks n=7 Participants
Mean Plasma Uric Acid Baseline	8.5 mg/dL Standard Deviation 1.21
Mean Plasma Uric Acid Week 3	4.0 mg/dL Standard Deviation 2.63
Mean Plasma Uric Acid Week 7	7.7 mg/dL Standard Deviation 5.61

Adverse Events

Pegloticase 8 mg Every 2 Wks

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pegloticase 8 mg Every 2 Wks n=7 participants at risk
Infections and infestations Cellulitis	14.3% 1/7 • Number of events 1 • 6 months
Metabolism and nutrition disorders Hyperglycaemia	14.3% 1/7 • Number of events 1 • 6 months

Other adverse events

Measure	Pegloticase 8 mg Every 2 Wks n=7 participants at risk
General disorders Infusion-Related Reaction	57.1% 4/7 • Number of events 7 • 6 months
General disorders Fatigue	14.3% 1/7 • 6 months
General disorders Oedema Peripheral	14.3% 1/7 • 6 months
Musculoskeletal and connective tissue disorders Gout (flare)	71.4% 5/7 • 6 months
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 2/7 • 6 months
Musculoskeletal and connective tissue disorders Back Pain	14.3% 1/7 • 6 months
Musculoskeletal and connective tissue disorders Shoulder Pain	14.3% 1/7 • 6 months
Infections and infestations Upper Respiratory Tract Infection	14.3% 1/7 • 6 months
General disorders Nausea	14.3% 1/7 • 6 months
Gastrointestinal disorders Vomiting	14.3% 1/7 • 6 months
Injury, poisoning and procedural complications Procedural Pain	14.3% 1/7 • 6 months
Metabolism and nutrition disorders Diabete Mellitus Non-Insulin Dependent	14.3% 1/7 • 6 months
Nervous system disorders Tremor	14.3% 1/7 • 6 months
Musculoskeletal and connective tissue disorders New Tophus	14.3% 1/7 • 6 months
Renal and urinary disorders Polyuria	14.3% 1/7 • 6 months
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • 6 months
Surgical and medical procedures Wound Drainage	14.3% 1/7 • 6 months
Vascular disorders Hypertension	14.3% 1/7 • 6 months

Additional Information

Chief Medical Officer

Savient Pharmaceuticals, Inc.

Phone: 732-418-9300

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60